Our products are manufactured using the highest quality standards.
Standardized and strictly controlled industrial manufacturing processes are followed, including automated aseptic filling, lyophilization, and finishing. All steps – from master cell banks to final filled products – are carried out on qualified equipment by qualified and skilled employees.
- Produced in a modern GMP-certified facility, including a full quality management system according to ISO 9001 & ISO 13485
- EU GMP certificates for manufacturing of monoclonal antibodies (phase I/II), infusion solutions and aseptic filling
- FDA-inspected for the CliniMACS® CD34 System